Supervisor, Aseptic/Sterile Fill – Rochester MI

Kelly Science and Clinical is currently recruiting for one qualified, full-time, permanent Aseptic/Sterile Fill Supervisor position in the Rochester, Michigan area for one of our clients in the pharmaceutical space.

Responsibilities:

• Oversees hourly operators by ensuring compliance with validated parameters and SOPs.
  

• Develops daily/weekly department work schedules, set priorities, and verifies availability of resources.
  

• Participates in scheduling meetings with the objectives of increased resource utilization.
  

• Responsive to changes in daily workflow and schedule and determines needs and redeploys resources and/or overtime to achieve delivery and customer service commitments.
  

• Adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation.
  

• Reviews batch records and supporting records prior to submission to Quality.
  

• Maintains a safe work environment.
  

• Completes in-process, set up checks and verification in alignment with SOPs.
  

• Understands and adheres to GDPs.
  

• Executes QMS assignments (CAPA, Deviation, Change Control, SOPs, etc.)
  

• Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control.
  

• Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure.
  

• Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes.
  

• Initiates and approves work orders for equipment repairs or modifications.
  

• Creates, reviews, and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety.
  

• Follow and comply with company Safety policies and OSHA Regulations
  

• Participates in development & maintenance of a safe manufacturing environment.
  

• Establishes methods in compliance with regulatory, plant, and corporate policies.
  

• Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions Supervisory.
  

• Reports production updates and schedule changes to team and/or at daily Huddle or SMART meetings
  

• Assigns manpower and initiates documentation of violations and disciplinary action with operators as required.
  

• Requests equipment and facility repairs, or modifications
  

• Understands and complies with Union Agreement
  

• Keeps manager informed of operations; elevates as needed Leadership.
  

• Reviews operational performance and drives improvement opportunities.
  

• Troubleshoots or resolves issues impeding department daily/weekly objectives/deliverables.
  

• Interfaces with suppliers of equipment or products and area consultants/experts
  

• Conducts/supports CMO audits or regulatory agency inspections.

Qualifications/Education/Skills:

• B.A./B.S. Degree in Science, Business, or related field or significant experience; B.A. /B.S. Degree in Packaging, Science and/or Management degree highly desired
  

• 1-3 years in Pharmaceutical Packaging, Operation or Quality Department with increasing levels of responsibility or equivalent Knowledge required.
  

• Knowledge of QMSs, Learning MSs (Trackwise, Master Control, and ComplianceWire respectively)
  

• Proficient in MS Office Suite, Kronos, Maximo
  

• Solid understanding of all current state, federal and local standards, and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA, and DEA
  

• NOTE: Personnel from outside the pharmaceutical industry or a directly related industry, i.e., medical devices, food, etc., may be considered after critical assessment of their industry related knowledge.
  

• Must be able to gain knowledge and expertise in aseptic processing.

Top preferred skills:

• BS degree is required for upward growth within the company. Science degree would be highly beneficial, such as chemistry, biology, microbiology degrees.
  

• Union experience as well as supervisor experience; must have demonstrated leadership experience.
  

• 1-3 years in Pharmaceutical Packaging, Operation or Quality

Trackwise software experience would be a huge plus as well as Compliance wire software, Infinity QS software, and QMS specific to batches.

PHYSICAL REQUIREMENTS:

• Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5.
  

• Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.
  

• Frequently working near or exposed to moving mechanical parts.
  

• The noise level is moderate.
  

• Occasional exposure to fumes, airborne particles, toxic, or caustic chemicals

Pay: $75-85K/yr and based on experience

Hours: 11PM – 730AMEST, M-F – 15% shift differential – some daily and weekend OT is required for this role. There is a stipend for additional OT hours worked as this is a salaried role.

For immediate consideration or more information, please contact me directly at Tierra.Barbour@kellyscientific.com or at 804-991-0745

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